Common use of Approval for Countries Outside Major Markets Clause in Contracts

Approval for Countries Outside Major Markets. For countries outside the Major Markets that Pharmaceutical Partners do not wish to include in the Major Markets under this Agreement but where RMS nonetheless desires to commercialize the RMS Product, Pharmaceutical Partners agree to reasonably cooperate in the preparation and/or exchange of any documentation necessary to support any INDs, NDAs, Device Authorization Applications or other applications for such Regulatory Approvals in such countries. For countries outside the Major Markets that RMS does not wish to include in the Major Markets under this Agreement but where Pharmaceutical Partners desire to commercialize the Pharmaceutical Partners Product, RMS agrees to reasonably cooperate in the preparation and/or exchange of any documentation necessary to support any INDs, NDAs, Device Authorization Applications or other applications for such Regulatory Approvals for an IVD in such countries. For clarity, RMS’ cooperation for preparation and/or exchange of documentation to support any Device Authorization Applications or other applications for such Regulatory Approvals for an IVD in such countries does not impart nor grant any implied licenses with respect to the RMS Product or to any RMS Background IP or RMS Project Invention for such IVD in the Diagnostic Field.

Appears in 4 contracts

Samples: Companion Diagnostics Agreement (Epizyme, Inc.), Companion Diagnostics Agreement, Companion Diagnostics Agreement (Epizyme, Inc.)

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